Results Further Support The Benefits Of TYSABRI For Multiple Sclerosis Patients



Results Further Support The Benefits Of TYSABRI For Multiple Sclerosis
Patients
14 Sep 2009

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) have
announced six-month results of an ongoing, one-year longitudinal,
observational, patient-reported outcomes study showing multiple
sclerosis (MS) patients taking TYSABRI® (natalizumab) experienced an
improvement in both their physical function and psychological well-
being. Findings from the study, which was performed in conjunction
with HealthCore Inc., a health-outcomes research company, are the
first attempt to assess patient experiences with TYSABRI in usual-care
settings. The data, presented at the 25th Congress of the European
Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS),
shows patients report TYSABRI has an impact in improving their overall
quality of life.

"The symptoms that an MS patient deals with on a daily basis result in
significant psychological and physical effects that can adversely
impact their quality of life," said William Stuart, M.D., medical
director of the Multiple Sclerosis Center of Atlanta. "In a previous
pivotal trial, TYSABRI not only showed a reduction in relapse rates
and disability progression, but also improved quality of life. Results
from this observational study further demonstrate the impact of
TYSABRI on improving MS patients' well-being as reported by patients
who live with this disease every day."

About the study

The study is assessing health outcomes from patients' perspectives
before starting TYSABRI and after the third, sixth and 12th infusions
of TYSABRI. A majority of the patients in the study are female (76.3%)
with mean age of 46.6 years and mean disease duration of 10 years.

After six TYSABRI infusions, patients reported statistically
significant improvement in:
Disease-specific quality of life (QoL), as measured by the Multiple
Sclerosis Impact Scale-29 (MSIS-29), which measures the physical
impact of MS in terms of mobility and self care, as well as the
psychological impact of MS in terms of anxiety/depression, with lower
scores indicating better QoL; and


General health-related QoL, as measured by the 12-item Short Form
Scale (SF-12) health survey, which assesses the physical and mental
health, with higher scores indicating better QoL.
Both scales assess patient experience of the physical and
psychological aspects of QoL. For the MSIS-29 subscales, there were
statistically significant improvements over time for both the physical
(baseline 46.87; third infusion 39.60; sixth infusion 39.27 (p<
0.001)) and psychological (baseline 41.56; third infusion 33.77; sixth
infusion 33.20 (p< 0.001)) impact scores.

SF-12 physical component summary (baseline 34.20; third infusion
36.05; sixth infusion 36.34 (p< 0.001)) and the SF-12 mental component
summary score (baseline 43.25, third infusion 47.35, sixth infusion
47.92 (p< 0.001)) showed statistically significant improvements over
time.

What do multiple sclerosis patients experience? Effect of natalizumab
on disease-specific quality of life over time (poster P872).

About TYSABRI

TYSABRI is approved in more than 40 countries. In the U.S., it is
approved for relapsing forms of MS and in the European Union for
relapsing-remitting MS. According to data from the Phase III AFFIRM
trial published in the New England Journal of Medicine, after two
years, TYSABRI treatment led to a 68 percent relative reduction (p<
0.001) in the annualized relapse rate, when compared with placebo, and
reduced the relative risk of disability progression by 42-54 percent
(p< 0.001).

TYSABRI is redefining success in the treatment of MS. In post-hoc
analyses of the Phase III AFFIRM trial and as published in The Lancet
Neurology, 37 percent of TYSBARI-treated patients remained free of
their MS activity, compared to seven percent of placebo-treated
patients. In addition, data has been presented showing that treatment
with TYSABRI significantly increased the probability of sustained
improvement in disability in patients with a baseline expanded
disability status scale (EDSS) score ≥ 2.0 by 69 percent relative to
placebo.

TYSABRI increases the risk of progressive multifocal
leukoencephalopathy (PML), an opportunistic viral infection of the
brain. Other serious adverse events that have occurred in TYSABRI-
treated patients include hypersensitivity reactions (e.g.,
anaphylaxis) and infections, including opportunistic and other
atypical infections. Clinically significant liver injury has been
reported in patients treated with TYSABRI in the post-marketing
setting. Common adverse events reported in TYSABRI-treated MS patients
include headache, fatigue, infusion reactions, urinary tract
infections, joint and limb pain and rash.

Source:
Shannon Altimari
Biogen Idec
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Article URL: http://www.medicalnewstoday.com/articles/163820.php

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